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Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Title
Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study
Authors
Matsuno, HiroakiKim, JinseokPark, Sung-HwanLee, Sang-HeonPark, Yong-BeomLee, Yun JongLee, Sang-IlPark, WonSheen, Dong HyukChoe, Jung-YoonChoi, Chan-BumHong, Seung-JaeSuh, Chang-HeeLee, Shin-SeokCha, Hoon-SukYoo, BinHur, Jin-WukLee, JisooTomomitsu, MasatoShin, SeonghyeLee, JiyoonSong, Yeong WookKim, Geun-TaeYoo, Wan-HeeBaek, Han JooShin, KichulShim, Seung CheolYang, Hyung-InKim, Hyun AhPark, Kyung-SuChoi, In AhPark, Min-Chan
Ewha Authors
이지수
SCOPUS Author ID
이지수scopus
Issue Date
2019
Journal Title
ARTHRITIS RESEARCH & THERAPY
ISSN
1478-6354JCR Link

1478-6362JCR Link
Citation
ARTHRITIS RESEARCH & THERAPY vol. 21
Keywords
EtanerceptLBEC0101Rheumatoid arthritisBiosimilarSwitch
Publisher
BMC
Indexed
SCIE; SCOPUS WOS
Document Type
Article
Abstract
Background: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). Methods: This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100. Results: A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively). Conclusions: Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.
DOI
10.1186/s13075-019-1910-2
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의과대학 > 의학과 > Journal papers
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